Safety Study of Home Oxygen Therapy for Children With Acute Bronchiolitis

This study has been completed.
Sponsor:
Information provided by:
Princess Margaret Hospital for Children
ClinicalTrials.gov Identifier:
NCT00677066
First received: May 8, 2008
Last updated: May 12, 2008
Last verified: May 2008
  Purpose

Home oxygen therapy is considered an appropriate and relatively safe option for children with chronic respiratory problems such as chronic lung disease of prematurity, but the use of home oxygen therapy for children with acute respiratory problems is limited. With the recent establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to determine the safety, parental satisfaction and economic advantage of home oxygen therapy for children with acute bronchiolitis compared with traditional inpatient hospitalization.


Condition Intervention Phase
Bronchiolitis
Procedure: Home oxygen therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial: Home Oxygen Therapy Versus Hospital Oxygen Therapy for Children With Acute Bronchiolitis

Resource links provided by NLM:


Further study details as provided by Princess Margaret Hospital for Children:

Primary Outcome Measures:
  • Readmission to hospital [ Time Frame: Within 7 days of discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of days in hospital [ Time Frame: days ] [ Designated as safety issue: No ]
  • parent satisfaction [ Time Frame: discharge ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Children discharged home with oxygen
Procedure: Home oxygen therapy
Administer oxygen at home or in hospital
Other Names:
  • Home oxygen
  • Hospital oxygen
No Intervention: 2
Children remain in hospital for oxygen therapy

Detailed Description:

Acute bronchiolitis is the most common reason for hospital admission in children aged less than 1 year in developed countries. Over the last 25 years, hospitalization rates and admission duration have increased dramatically, resulting in substantial health care costs for both institutions and individual families.

There are currently no pharmacological therapies for acute bronchiolitis that have been shown to consistently alter the natural history of this disease. Current evidence suggests that management is essentially supportive, consisting of oxygen supplementation if the child is hypoxic and nasogastric feeds or intravenous fluids if the child is dehydrated. Oxygen supplementation is the principal determinant of the length of hospital admission for children with acute bronchiolitis and the need for supplemental oxygen is generally considered to be an absolute indication for hospitalization. However, Bajaj et al demonstrated that a carefully selected population of children with acute bronchiolitis can be managed safely with home oxygen therapy.

The escalating demand and cost of health care has driven health reforms in many countries, including Australia and the United Kingdom. These reforms have included the development of services that allow patients with a range of illnesses to be managed safely in their own home rather than hospital. Such services have been well established for children with a number of chronic conditions and although managing children with acute illnesses at home is not a new strategy, this model of care is increasingly considered an alternative to traditional in-patient hospitalisation. In addition to the financial benefits of transferring care to the patients' homes for health care providers and families, children and parents report a strong preference for such models of care.

Home oxygen therapy is considered an appropriate and relatively safe option for children with chronic respiratory problems such as chronic lung disease of prematurity, but the use of home oxygen therapy for children with acute respiratory problems is limited. With the recent establishment of a "Hospital in The Home" (HiTH) program at our institution, we sought to determine the safety, parental satisfaction and economic advantage of home oxygen therapy for children with acute bronchiolitis compared with traditional inpatient hospitalization.

  Eligibility

Ages Eligible for Study:   3 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 3 - 24 months of age (corrected gestation)
  2. Clinical diagnosis of acute bronchiolitis
  3. Adequate feeding (>50% normal) & hydration
  4. O2 saturation >92% on <1litre/minute nasal cannula oxygen.
  5. Observed and clinically stable for at least 24 hours in hospital
  6. Pass modified "safety in air test "
  7. Caregivers must be counseled about risk of smoking around a child receiving oxygen supplementation
  8. Caregivers must be adequately educated about home oxygen
  9. HiTH nurses able to visit at home at least twice daily, in addition to daily phone call
  10. Paediatrician agrees that child is eligible for recruitment in study

Exclusion Criteria:

  1. Pre-existing cardiac, pulmonary (including chronic lung disease of infancy, cystic fibrosis and congenital or acquired airway anomalies), and neuromuscular disorders
  2. History of apnea
  3. Prematurity <34 weeks gestation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677066

Locations
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Sponsors and Collaborators
Princess Margaret Hospital for Children
Investigators
Principal Investigator: Andrew C Martin, FRACP Princess Margaret Hospital for Children
  More Information

No publications provided

Responsible Party: Dr Andrew Martin, Princess Margaret Hospital for Children
ClinicalTrials.gov Identifier: NCT00677066     History of Changes
Other Study ID Numbers: EP 1405
Study First Received: May 8, 2008
Last Updated: May 12, 2008
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Princess Margaret Hospital for Children:
bronchiolitis
oxygen
children

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 01, 2014